Difference between revisions of "Inotuzumab ozogamicin (Besponsa)"

Revision as of 13:26, 23 August 2017

General information

Class/mechanism: Antibody targeting CD22, conjugated with a cytotoxic, antitumor antibiotic (calicheamicin). Inotuzumab demonstrates a dose-dependent cytotoxicity both in vitro and in vivo. ^[1]
Route: IV
Extravasation: No information.

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

Patient drug information

No information available.

History of changes in FDA indication

8/17/2017: FDA approved "for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)."

Also known as

Code name: CMC-544
Brand name: Besponsa

References

↑ ClinicalTrials.Gov website

[1] ClinicalTrials.Gov website

[1]

@@ Line 6: / Line 6: @@
 For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer.  Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.
-==Preliminary data==
+==Diseases for which it is used==
+*[[B-cell acute lymphoblastic leukemia]]
-===[[B-cell acute lymphoblastic leukemia]]===
+*[[Diffuse large B-cell lymphoma]]
-# Kantarjian H, Thomas D, Jorgensen J, Jabbour E, Kebriaei P, Rytting M, York S, Ravandi F, Kwari M, Faderl S, Rios MB, Cortes J, Fayad L, Tarnai R, Wang SA, Champlin R, Advani A, O'Brien S. Inotuzumab ozogamicin, an anti-CD22-calecheamicin conjugate, for refractory and relapsed acute lymphocytic leukaemia: a phase 2 study. Lancet Oncol. 2012 Apr;13(4):403-11. Epub 2012 Feb 21. [http://www.sciencedirect.com/science/article/pii/S1470204511703862 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/22357140 PubMed]
+*[[Follicular lymphoma]]
-# '''Abstract:''' Susan O'Brien, Deborah A. Thomas, Elias Jabbour, Stefan Faderl, Farhad Ravandi, Gautam Borthakur, Sergernne York, Rebecca Garris, Jorge E. Cortes, Hagop M. Kantarjian. Inotuzumab Ozogamicin In Combination With Low-Intensity Chemotherapy (Mini-hyper-CVD) As Frontline Therapy For Older Patients (≥60 years) With Acute Lymphoblastic Leukemia (ALL). Blood Nov 2013,122(21)1432 [http://bloodjournal.hematologylibrary.org/content/122/21/1432 link to original abstract]
-# Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gökbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. Epub 2016 Jun 12. [http://www.nejm.org/doi/full/10.1056/NEJMoa1509277 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27292104 PubMed]
-===[[Diffuse large B-cell lymphoma]]===
-# Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Giné E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. Epub 2013 Jan 7. [http://jco.ascopubs.org/content/31/5/573.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/23295790 PubMed]
-===[[Follicular lymphoma]]===
-# Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Giné E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. Epub 2013 Jan 7. [http://jco.ascopubs.org/content/31/5/573.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/23295790 PubMed]
-# Goy A, Forero A, Wagner-Johnston N, Christopher Ehmann W, Tsai M, Hatake K, Ananthakrishnan R, Volkert A, Vandendries E, Ogura M. A phase 2 study of inotuzumab ozogamicin in patients with indolent B-cell non-Hodgkin lymphoma refractory to rituximab alone, rituximab and chemotherapy, or radioimmunotherapy. Br J Haematol. 2016 Aug;174(4):571-81. Epub 2016 Apr 22. [http://onlinelibrary.wiley.com/wol1/doi/10.1111/bjh.14094/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27101934 PubMed]
 ==Patient drug information==